Pleurectomy/Decortication Followed By Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Memorial Sloan Kettering Cancer Center
Sponsor:
Collaborators:
Eli Lilly and Company
M.D. Anderson Cancer Center
University of Pennsylvania
Mayo Clinic
Brigham and Women's Hospital
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00715611
First received: July 11, 2008
Last updated: April 14, 2016
Last verified: April 2016

July 11, 2008
April 14, 2016
July 2008
July 2017   (final data collection date for primary outcome measure)
number of patients ≥ grade 3 pneumonitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Grade 3 pneumonitis is defined as symptomatic, interfering with ADL's and requiring oxygen support as defined by the NCI Common Terminology Criteria (CTC) version 4.0 for toxicity and Adverse Event reporting.
To determine the safety (specifically in regards to pneumonitis) of chemotherapy followed by IMRT in patients with unresectable malignant pleural mesothelioma. [ Time Frame: conclusion of study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00715611 on ClinicalTrials.gov Archive Site
Not Provided
  • The response rate, progression free and overall survival rates of patients with unresectable malignant pleural mesothelioma treated with chemotherapy followed by IMRT to the pleura. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the relationship between response to treatment and the levels of soluble mesothelin-related peptide (SMRP) and osteopontin. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To determine the pattern of progression: local recurrence versus metastatic disease. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pleurectomy/Decortication Followed By Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma
Phase II Toxicity Study of Pleurectomy/Decortication Followed By Adjuvant Chemotherapy and Intensity Modulated Radiation Therapy to the Pleura in Patients With Locally Advanced Malignant Pleural Mesothelioma
For patients with this type of cancer, the standard of care is treatment with chemotherapy. Radiation therapy is typically not used. This is because radiation to the entire lining of the lung has many side effects that are often severe including damage to the lung (pneumonitis). There is a new radiation technique using Intensity Modulated Radiation Therapy (IMRT) that has been shown to reduce many of the side effects of standard radiation therapy. This type of radiation therapy specifically targets the lining of the lung, where you have your cancer, and reduces the risk of damaging the lung itself. The purpose of this study is to test the safety and implementation of standard pleurectomy/decortication (removal of the surface lining of the lung) performed at other centers. Patients will undergo pleurectomy/decortication followed by chemotherapy then hemithoracic pleural IMRT to the pleura in patients with malignant pleural mesothelioma.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mesothelioma
  • Procedure: Pleurectomy/Decortication
    Pleurectomy/decortication will be performed as per standard technique
    Other Name: (P/D)
  • Drug: pemetrexed and cisplatin or carboplatin
    The combination of pemetrexed and cisplatin or carboplatin will be given every 3 weeks for up to 4 cycles. Pemetrexed will be administered at 500mg/m2 as a 10-minute infusion. Cisplatin will be administered at 75mg/m2 as a 60-minute infusion. Carboplatin will be administered at an AUC of 5 over 30 minutes.
  • Radiation: Intensity Modulated Radiation Therapy
    IMRT will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions with an optional SIB to gross residual disease (pending meeting normal tissue constraints).
    Other Name: IMRT
Experimental: 1
This is a multicenter phase II toxicity study of pleurectomy/decortication (P/D) followed by adjuvant chemotherapy and Intensity Modulated Radiation Therapy (IMRT) to the pleura in patients with malignant pleural mesothelioma. Patients deemed resectable at the time of enrollment will undergo P/D with the goal of a macroscopic complete resection (MCR). Those with disease progression or severe toxicity will stop chemotherapy and undergo a PET scan.
Interventions:
  • Procedure: Pleurectomy/Decortication
  • Drug: pemetrexed and cisplatin or carboplatin
  • Radiation: Intensity Modulated Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
81
July 2017
July 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provide written informed consent to participate on the study
  • Patients must have a pathologically confirmed diagnosis either at MSKCC or at the participating site of stage I-III malignant pleural mesothelioma amenable to P/D.
  • Epithelioid or biphasic histology subtype
  • No evidence of metastatic disease.
  • Patient age ≥ 18 years but ≤ 80 years at the time of consent.
  • Karnofsky performance status ≥ 80%
  • Pulmonary Function Tests:

    1. FEV1 ≥ 35% (corrected for Hgb) of predicted postoperative (ppoFEV1) (as if the patient underwent a pneumonectomy) based on the following formula using the quantitative V/Q scan:

    °Predicted post-resection FEV1 = FEV1 x % perfusion to uninvolved lung from the quantitative V/Q scan report

  • DLCO > 40% predicted (corrected for Hgb)
  • Patient must have adequate organ function as indicated by the following laboratory values:

    1. Absolute neutrophil count ≥1.5 K/mcL
    2. Platelets ≥100 K/mcL
    3. Serum total bilirubin ≤ 1.5 X ULN
    4. AST (SGOT) or ALT (SGPT) ≤ 3.0 X ULN
  • In cases of concern about renal toxicity from chemotherapy, an optional nuclear medicine kidney function scan may be performed prior to radiation therapy to determine the functional contribution of each kidney.
  • Reassessment after P/D: Confirmation of resection status postoperatively, prior to proceeding with adjuvant chemotherapy and pleural IMRT

Exclusion Criteria:

  • Sarcomatoid or desmoplastic histology
  • Continuous oxygen use
  • Prior nephrectomy on the contralateral side of MPM
  • Prior systemic therapy (e.g. chemotherapy/biological agents) for mesothelioma
  • Prior intrapleural therapy (except pleurodesis) or intrapleural therapy at the time of P/D
  • Prior thoracic radiation therapy preventing hemithoracic pleural IMRT
  • Bulky disease in the fissure preventing lung-sparing pleural IMRT
  • Patients undergoing extrapleural pneumonectomy
  • Patients with an active infection that require systemic antibiotics, antiviral, or antifungal treatments
  • Patients with a concurrent active malignancy (except squamous or basal cell carcinoma of the skin)
  • Patients with serious unstable medical illness
  • Presence of third space fluid that cannot be controlled by drainage
  • For patients who develop or have baseline clinically significant pleural effusions before or during initiation of pemetrexed therapy; consideration should be given to drain the effusion prior to dosing
  • No acute congestive heart failure
  • Pregnant or lactating women
  • Men or women not using effective contraception

Reproductive risks Patients should not become pregnant or father a baby while on this study because the drugs in this study can affect an unborn baby. Women should not breast-feed a baby while on this study. Women of childbearing age will be counseled to use birth control while on this study.

Both
18 Years to 80 Years   (Adult, Senior)
No
Contact: Andreas Rimner, MD 212-639-6025
Contact: Valerie Rusch, MD 212-639-5873
United States
 
NCT00715611
08-053
Not Provided
Not Provided
Not Provided
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
  • Eli Lilly and Company
  • M.D. Anderson Cancer Center
  • University of Pennsylvania
  • Mayo Clinic
  • Brigham and Women's Hospital
Principal Investigator: Andreas Rimner, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP